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Result Summary for 580299/003

Result Summary
Protocol ID: 580299/003
Clinical Study ID: 580299-003 (HPV-003 [Mi-CP-058])
Official Title: A Phase I/II Study to evaluate the safety and immunogenicity of MEDI-517, a virus-like particle vaccine against human papillomavirus (HPV) types 16 and 18, in healthy adult female volunteers who are HPV-16 or HPV-18 DNA positive
Phase: Phase 1/2
Study Indications or Diseases:
  • Papillomavirus Vaccines
Generic Name: Human Papillomavirus Types 16 and 18 Vaccine
Trade/Product Name: Cervarix;Cervarix
Approved Drug Label: http://www.gsk.com/products.html
Results Summary: Click here to download result summary. Click here to download result summary.
Citations:
  • Descamps D et al. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008.
  • Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
  • Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.

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